Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients

Study Description

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Brief Summary:

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Condition or disease	Intervention/treatment	Phase
Chronic Heart Failure	Drug: rhNRG-1; Drug: Placebo	Phase 3

Detailed Description:

The mortality of chronic heart failure patients remains high, in spite of current treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	679 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
Study Start Date :	February 2012
Actual Primary Completion Date :	August 2017
Actual Study Completion Date :	August 2017

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; placebo in addition to standard therapy	Drug: Placebo; 10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks
Experimental: rhNRG-1; rhNRG-1 in addition to standard therapy	Drug: rhNRG-1; 10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks

Outcome Measures

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Primary Outcome Measures :

1. All-cause mortality [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. sudden death [ Time Frame: 1 year ]
2. death caused by cardiovascular events [ Time Frame: 1 year ]
3. rehospitalization [ Time Frame: 1 year ]
4. hospitalization caused by worsening heart failure [ Time Frame: 1 year ]
5. cardiac function [ Time Frame: 1 year ]
6. NYHA functional classification [ Time Frame: 1 year ]
7. 6 minute walking distance [ Time Frame: 1 year ]
8. quality of life [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Age between 18 and 75, both sex.
2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
3. NYNA functional class II OR III.
4. Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month.
5. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month.
6. Capable of signing the informed consent form.

Exclusion Criteria:

1. new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
2. NYNA functional class I OR IV.
3. Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
4. Ischemic heart failure without recanalization or with recanalization in recent six months.
5. acute MI in the last 3 months.
6. unstable angina.
7. Patients with acute pulmonary edema or acute hemodynamic disorder.
8. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month.
9. Patients with right heart failure caused by pulmonary disease.
10. Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml).
11. Cardiac surgery or cerebrovascular accident within recent six months.
12. Preparing for heart transplantation or CRT, or has received CRT.
13. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate).
14. Serious hepatic or renal dysfunction (Cr＞2.0mg/dl, AST or ALT 5 times above the normal upper limit).
15. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
16. Systolic blood pressure <90mmHg or >160mmHg.
17. Pregnant or plan to pregnant.
18. Patients who participated in any clinical trial in the recent three months.
19. Subject with a life expectancy less than 6 months as assessed by the investigator.
20. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
21. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
22. Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
23. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).

Contacts and Locations

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  Show 46 Study Locations

Sponsors and Collaborators

Zensun Sci. & Tech. Co., Ltd.

Investigators

Principal Investigator:	Runlin Gao, MD, Ph.D	Cardiovascular Institute and Fuwai Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01541202 History of Changes
Other Study ID Numbers:	ZS-01-305
First Posted:	February 29, 2012
Last Update Posted:	December 21, 2017
Last Verified:	February 2012

Keywords provided by Zensun Sci. & Tech. Co., Ltd.:

chronic heart failure; neuregulin; mortality

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases